(67 days)
Dental casting alloy for making restoration. (NOT FOR USE WITH DENTAL PORCELAIN )
Silver-palladium based casting alloy
The document provided is a 510(k) premarket notification for a dental casting alloy, not a medical device that utilizes an algorithm or AI. Therefore, the concepts of acceptance criteria for algorithm performance, study design with human readers, ground truth, and training/test sets are not applicable.
The "acceptance criteria" in this context refer to the demonstration of substantial equivalence to a legally marketed predicate device, based on similar technological characteristics (composition, physical, and mechanical properties) and intended use.
Here's the information extracted from the document, rephrased to fit the context of device equivalence rather than algorithm performance:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly defined by the properties of the legally marketed predicate device, Jelenko Albacast. The new device, Aurecast GF, is deemed to meet these criteria if its properties are substantially similar, especially for critical attributes.
| Property | Predicate Device (Albacast) | New Device (Aurecast GF) | Acceptance Criterion (Implicitly "Substantially Similar") |
|---|---|---|---|
| Composition (weight%) | |||
| Ag | 70 | 72.1 | Concentration difference |
§ 872.3060 Noble metal alloy.
(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.